Medical Device and Method for Treatment of a Sinus Opening

ABSTRACT

A medical device and method for the treatment of a sinus opening includes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism and a balloon catheter movement mechanism. The handle has proximal and distal ends and a longitudinal axis along the length of the handle. The guide catheter is attached to the distal end of the handle and has a catheter lumen. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism and the balloon catheter movement mechanism are both operatively disposed on the handle. In addition, the guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and catheter lumen by user operation of the guide wire movement mechanism. Moreover, the guide wire movement mechanism includes an integrated guide wire locking and rotation mechanism configured for rotation of the guide wire and for securely locking and unlocking the guide wire to the guide wire movement mechanism. Furthermore, the balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter through the handle and catheter lumen by user operation of the balloon catheter movement mechanism.

RELATED APPLICATIONS

This application claims priority pursuant to 35 U.S.C. §119 to U.S.Provisional Patent Application Ser. No. 61/385,250, entitled “MedicalDevice for Treatment of a Sinus Opening” filed on Sep. 22, 2010, U.S.Provisional Patent Application Ser. No. 61/385,263, entitled “Method forTreating a Sinus Opening” filed on Sep. 22, 2010 and U.S. ProvisionalPatent Application Ser. No. 61/511,237, entitled “Medical Device andMethod for Treatment of a Sinus Opening” filed on Jul. 25, 2011, theentirety of these applications being incorporated herein by referencethereto.

FIELD OF THE INVENTION

The present invention relates, in general, to medical devices and, inparticular, to medical devices and related methods for the treatment ofsinus conditions.

BACKGROUND OF THE INVENTION

The paranasal sinuses are hollow cavities in the skull connected bysmall openings, known as ostia, to the nasal canal. Each ostium betweena paranasal sinus and the nasal cavity is formed by a bone covered by alayer of mucosal tissue. Normally, air passes into and out of theparanasal sinuses through the ostia. Also, mucus is continually formedby the mucosal lining of the sinuses and drains through the ostia andinto the nasal canal.

Sinusitis is a general term that refers to inflammation in one or moreof the paranasal sinuses. Acute sinusitis can be associated with upperrespiratory infections or allergic conditions, which may cause tissueswelling and temporarily impede normal trans-ostial drainage andventilation of the sinuses, thereby resulting in some collection ofmucus and possibly infection within the sinus cavities. Chronicsinusitis is a long term condition characterized by persistent narrowingor blockage of one or more sinus ostia, resulting in chronic infectionand inflammation of the sinuses. Chronic sinusitis is often associatedwith longstanding respiratory allergies, nasal polyps, hypertrophicnasal turbinates and/or deviated internasal septum. While acutesinusitis is typically caused by infection with a single pathogen (e.g.,one type of bacteria, one type of virus, one type of fungus, etc.),chronic sinusitis is often associated with multiple pathogen infections(e.g., more than one type of bacteria or more than one genus ofmicro-organism).

Chronic sinusitis, if left untreated, can result in irreparable damageto the tissues and/or bony structures of the paranasal anatomy. Theinitial treatment of chronic sinusitis usually involves the use of drugssuch as decongestants, steroid nasal sprays and antibiotics (if theinfection is bacterial). In cases where drug treatment alone fails toprovide permanent relief, surgical intervention may be indicated.

The most common surgical procedure for treating chronic sinusitis isfunctional endoscopic sinus surgery (FESS). FESS is commonly performedusing an endoscope and various rigid instruments inserted through thepatient's nostril. The endoscope is used to visualize the positioningand use of various rigid instruments used for removing tissue from thenasal cavity and sinus ostia in an attempt to improve sinus drainage.

A technique known as the Balloon Sinuplasty™ procedure and a system forperforming the procedure have been developed by Acclarent Inc, of MenloPark, Calif. for treatment of sinusitis. A number of US patents andpatent applications including U.S. Pat. Nos. 7,645,272, 7,654,997, and7,803,150 and Publications 2008/0097154 and 2008/0281156 each of whichis hereby incorporated in full by reference, describe variousembodiments of the Balloon Sinuplasty™ procedure as well as variousdevices useable in the performance of such procedure. In the BalloonSinuplasty™ procedure, a guide catheter is inserted into the nose andpositioned within or adjacent to the ostium of the affected paranasalsinus. A guidewire is then advanced through the guide catheter and intothe affected paranasal sinus. Thereafter, a dilation catheter having anexpandable dilator (e.g. an inflatable balloon) is advanced over theguidewire to a position where the dilator is positioned within theostium of the affected paranasal sinus. The dilator is then expanded,causing dilation of the ostium and remodelling of bone adjacent to theostium, without required incision of the mucosa or removal of any bone.The catheters and guidewire are then removed and the dilated ostiumallows for improved drainage from and ventilation of the affectedparanasal sinus. There is a continuing need for improved methods anddevices for treating the paranasal sinus.

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings, in which like numerals indicate like elements.

SUMMARY OF THE INVENTION

The present invention provides devices and methods for treating a sinusopening.

In one aspect, a medical device is provided for the treatment of a sinusopening. The medical device includes a handle with a proximal end, adistal end, and a longitudinal axis along the length of the handle. Thedevice further includes a guide catheter attached to the distal end ofthe handle, the guide catheter having a catheter lumen. The medicaldevice further includes a guide wire movement mechanism operativelydisposed on the handle, and a balloon catheter movement mechanismoperatively disposed on the handle. The handle and the catheter lumenare configured for operatively accepting a guide wire and a ballooncatheter. The guide wire movement mechanism is configured foradvancement and retraction of a guide wire disposed at least partiallyin the handle and the catheter lumen through the handle and the catheterlumen by user operation of the guide wire movement mechanism. The guidewire movement mechanism includes an integrated guide wire locking androtation mechanism configured for rotation of the guide wire and forsecurely locking and unlocking the guide wire to the guide wire movementmechanism. The balloon catheter movement mechanism is configured foradvancement and retraction of a balloon catheter disposed at leastpartially in the handle and in the catheter lumen through the handle andcatheter lumen by user operation of the balloon catheter movementmechanism.

In one embodiment, the medical device may further include a guide wiredisposed at least partially in the handle and catheter lumen and aballoon catheter disposed at least partially in the handle and thecatheter lumen.

In another embodiment, the balloon catheter movement mechanism of themedical device may be configured for advancement and retraction of theballoon catheter through the handle and catheter lumen by user operationof the balloon catheter movement mechanism involving translation of theballoon catheter movement mechanism relative to the handle, by useroperation of the balloon catheter movement mechanism involvinglongitudinal sliding of the balloon catheter movement mechanism alonghandle or by user operation of the balloon catheter movement mechanisminvolving rotation of at least a portion of the balloon cathetermovement mechanism.

In a further embodiment, the guide wire movement mechanism of themedical device is configured for advancement and retraction of the guidewire through the handle and the catheter lumen by user operation of theguide wire movement mechanism involving translation of the guide wiremovement mechanism relative to the handle or by user operation of theguide wire movement mechanism involving longitudinal sliding of theguide wire movement mechanism along the handle.

In another embodiment of the medical device, the guide catheter isconfigured for attachment, detachment and reattachment to the handle orthe device further includes a guide tip configured for attachment,detachment and reattachment to the guide catheter.

In another embodiment of the medical device, a suction pathway isincluded for removal or material from the paranasal sinus or the sinuscanal or an irrigation cartridge is included for irrigating theparanasal sinus or sinus canal.

In a further embodiment, the medical device includes a guide wiresupport disposed within the handle. The guide wire is at least partiallydisposed within the guide wire support and the guide wire support isconfigured to prevent buckling of the guide wire within the handleduring advancement of the guide wire through the handle. The guide wiresupport may be generally cylindrical in shape and may include aslit-shaped opening configured such that, during advancement of theguide wire, the guide wire enters the guide wire support via theslit-shaped opening.

In another embodiment of the medical device, the guide wire locking androtation mechanism includes a barrel with an axial opening and a colletaxle at least partially disposed within the axial opening of the barrel.

In a further embodiment of the medical device, the guide wire movementmechanism includes at least one rail configured for sliding movement ofthe guide wire mechanism along a length of the handle during advancementand retraction of the guide wire.

In yet another embodiment of the medical device, the balloon cathetermovement mechanism includes at least one rail configured for slidingmovement of the balloon catheter mechanism along a length of the handleduring advancement and retraction of the balloon catheter.

In another embodiment the guide wire movement mechanism and the ballooncatheter movement mechanism are disposed on the handle in aconfiguration for single-handed operation of both the guide wiremovement mechanism and the balloon catheter movement mechanism by auser. The guide wire movement mechanism and the balloon cathetermovement mechanism may be disposed on the handle in an in-lineconfiguration along the length of the handle or in a side-by-sideconfiguration.

In another embodiment of the medical device, the sinus opening fortreatment may be at least one of a Frontal sinus opening, Maxillarysinus opening, and Sphenoid sinus opening.

In yet another embodiment of the medical device, the guide wire lockingand rotation mechanism is configured for thumb-operated rotation orsingle finger operated rotation of the guide wire.

In another aspect, a method is provided for treating a sinus opening.The method includes inserting a medical device for the treatment of asinus opening partially into a patient's anatomy, positioning themedical device in the sinus opening, advancing a guide wire of themedical device into the patient's sinus via user operation of a guidewire movement mechanism of the medical device disposed on a handle ofthe medical device, rotating the guide wire within the patient's sinusvia user operation of an integrated guide wire locking and rotationmechanism of the guide wire movement mechanism, repeating the guide wireadvancing and rotating steps to position the guide wire in the sinusopening as appropriate for treatment, advancing a balloon catheter ofthe medical device along the guide wire via user operation of a ballooncatheter movement mechanism of the medical device disposed on the handleof the medical device, and treating the sinus opening via inflation ofthe balloon catheter.

In one embodiment of the method, advancing the guide wire includes useroperation of the guide wire movement mechanism involving translation ofthe guide wire movement mechanism relative to the handle or longitudinalsliding of the guide wire movement mechanism along the handle

In another embodiment of the method, advancing the balloon catheterincludes user operation of the balloon catheter movement mechanisminvolving translation of the balloon catheter movement mechanismrelative to the handle, longitudinal sliding of the balloon cathetermovement mechanism along handle, or rotation of at least a portion ofthe balloon catheter movement mechanism.

In a further embodiment, the method may further include deflating theballoon catheter, retracting the balloon catheter and the guide wire,and removing the medical device from the patient's anatomy.

In another embodiment, the method may include attaching, prior to theinserting step, a detachable guide tip to the medical device in anorientation appropriate for the sinus opening to be treated orattaching, prior to the inserting step, a detachable guide catheter tothe medical device in an orientation appropriate for the sinus openingto be treated.

In a further embodiment of the method, the guide wire advancing step mayinclude advancing the guide wire through a guide wire support disposedin the handle of the medical device and configured to prevent bucklingof the guide wire in the handle.

In another embodiment of the method, the guide wire support isessentially cylindrical in shape and includes a slit-shaped openingthrough which the guide wire is directed by the guide wire movementmechanism.

In a further embodiment of the method, the patient's anatomy is anostril and the sinus opening may be one of a Frontal sinus opening,Maxillary sinus opening, and Sphenoid sinus opening.

In another embodiment of the method, the guide wire movement mechanismand the balloon catheter movement mechanism are disposed on the handlein a configuration for single-handed user operation of both the guidewire movement mechanism and the balloon catheter movement mechanism by auser and may be in an in-line configuration along the length of thehandle.

In other embodiments of the method, the guide wire locking and rotationmechanism is configured for thumb-operated or single finger operatedrotation of the guide wire.

In a further embodiment, the method may include irrigating the sinusopening using the medical device and the irrigating may be accomplishedusing an irrigation cartridge installed in the medical device or anirrigation balloon catheter incorporated into the medical device.

In yet another embodiment, the method may include suctioning the sinusopening using the medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified perspective view of a medical device for thetreatment of a sinus opening according to an embodiment of the presentinvention.

FIG. 2 is a simplified side view of the medical device of FIG. 1.

FIG. 3 is a simplified side view of the medical device of FIG. 1 with aguide wire of the medical device advanced.

FIG. 4 is a simplified side view of the guide wire, balloon catheter,balloon catheter movement mechanism, guide wire movement mechanism andguide wire support of the medical device of FIG. 1 with a balloonworking segment of the balloon catheter shown in an inflated state forclarity.

FIG. 5 is a simplified perspective view of the guide wire, ballooncatheter, balloon catheter movement mechanism, guide wire movementmechanism and guide wire support of the medical device of FIG. 4.

FIG. 6 is a simplified perspective view of a medical device for thetreatment of a sinus opening (absent a guide wire, guide tip and ballooncatheter) according to another embodiment of the present invention.

FIGS. 7A and 7B are simplified side and cross-sectional views,respectively, of the medical device of FIG. 6.

FIG. 8 is a simplified depiction of a portion of a guide catheter andthree detachable guide tips as can be employed in a medical deviceaccording to embodiments of the present invention.

FIG. 9 is a simplified cross-sectional depiction of a balloon catheteras can be employed in medical devices according to the presentinvention.

FIG. 10 is a combined longitudinal and triple cross-sectional depictionof a portion of the balloon catheter of FIG. 9 along with a portion of aguide wire.

FIG. 11 is a simplified side view of a guide wire movement mechanism andguide wire of the medical device of FIG. 6.

FIG. 12 is a simplified cross-sectional view of the guide wire movementmechanism and guide wire of FIG. 11 in a locked position.

FIG. 13 is a simplified cross-sectional view of the guide wire movementmechanism and guide wire of FIG. 11 in an unlocked position.

FIG. 14 is a simplified transparent view of the guide wire movementmechanism and guide wire of FIG. 11 in the absence of the barrel of theguide wire movement mechanism.

FIGS. 15A, 15B, and 15C are simplified perspective, top and side views,respectively, of a guide wire support as can be employed in medicaldevices according to the present invention with FIG. 15B also depictinga guide wire.

FIG. 16 is a simplified perspective view of the guide wire, ballooncatheter, balloon catheter movement mechanism, guide wire movementmechanism and guide wire support of the medical device of FIG. 6 withthe balloon working segment shown in an inflated state for clarity.

FIGS. 17A, 17B and 17C are a sequence of simplified perspective views ofthe guide wire, balloon catheter, balloon catheter movement mechanism,guide wire movement mechanism and guide wire support of FIG. 16depicting the advancement of the guide wire by movement of the guidewire through a window opening of the guide wire support (FIGS. 17A and17B) and through a slit of the guide wire support (FIG. 17C).

FIG. 18 is a simplified side view of the medical device of FIG. 6depicting the guide wire movement mechanism in an advanced position.

FIG. 19 is a simplified side view of the medical device of FIG. 6depicting the guide wire movement mechanism in an advanced position andwith arrows indicating how rotational movement of the barrel of theguide wire movement mechanism serves to rotate the guide wire.

FIG. 20 is a simplified side view of the medical device of FIG. 6depicting the guide wire movement mechanism in a fully advancedposition.

FIG. 21 is a simplified side view of the medical device of FIG. 6depicting the balloon movement mechanism in a fully advanced position.

FIG. 22 is a simplified side view of the medical device of FIG. 6depicting the balloon movement mechanism and the guide wire movementmechanism in a retracted position.

FIG. 23 is a flow diagram depicting stages in a method for treating asinus opening according to an embodiment of the present invention.

FIG. 24 is a cross-sectional view of a medical device for the treatmentof a sinus opening according to an alternative embodiment of the presentinvention.

FIG. 25 is a partially exploded view of the device of FIG. 24.

FIG. 26A shows a collection of sinus guide catheters useful forpositioning of the sinus balloon catheters of the invention.

FIGS. 26B and 26C show detailed views of portions of the guide cathetersshown in FIG. 26A.

FIGS. 27A and 27B are views of the guide catheter locking mechanism ofthe device of FIG. 24 for 8 different rotational orientations accordingto the invention.

FIG. 28 is an enlarged perspective view of the device of FIG. 24 showingthe suction pathway according to the invention.

FIG. 29 is an enlarged perspective view of the guide wire actuator ofthe device of FIG. 24.

FIGS. 30A and 30B are top and side views of the balloon catheter of thedevice of FIG. 24 according to the invention and FIG. 30C shows furtherdetail of the side view shown in FIG. 30B.

FIGS. 31A, 31B and 31C are top views of the device of FIG. 24 showing aguide wire lock mechanism according to the invention. FIG. 31D is a sideview of the locking tab of the device of FIG. 24 for securing theballoon catheter actuator according to the invention.

FIG. 32 is a perspective view of the balloon catheter actuator of thedevice of FIG. 24 for guide wire manipulation without the wire actuatoraccording to an alternative embodiment of the invention.

DETAILED DESCRIPTION OF INVENTION

The following detailed description should be read with reference to thedrawings, in which like elements in different drawings are identicallynumbered. The drawings, which are not necessarily to scale, depictexemplary embodiments for the purpose of explanation only and are notintended to limit the scope of the invention. The detailed descriptionillustrates by way of example, not by way of limitation, the principlesof the invention. This description will clearly enable one skilled inthe art to make and use the invention, and describes severalembodiments, adaptations, variations, alternatives and uses of theinvention, including what is presently believed to be the best mode ofcarrying out the invention.

As used herein, the terms “about” or “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein.

In general, medical devices for the treatment (e.g., BalloonSinuplasty™) of a sinus opening (for example, a Frontal, Maxillary, orSphenoid sinus opening) according to embodiments of the presentinvention include a handle, a balloon catheter, a guide catheter, aguide wire, a guide wire movement mechanism and a balloon cathetermovement mechanism. The handle has proximal and distal ends and alongitudinal axis along the length of the handle. The guide catheter isattached to the distal end of the handle and has a catheter lumen.Moreover, the handle and catheter lumen are configured for operativelyaccepting a guide wire and a balloon catheter. The guide wire movementmechanism and the balloon catheter movement mechanism are bothoperatively disposed on the handle. In addition, the guide wire movementmechanism is configured for advancement and retraction of a guide wireat least partially disposed in the handle and catheter lumen through thehandle and catheter lumen by user operation of the guide wire movementmechanism. Moreover, the guide wire movement mechanism includes anintegrated guide wire locking and rotation mechanism configured forrotation of the guide wire and for securely locking and unlocking theguide wire to the guide wire movement mechanism. Furthermore, theballoon catheter movement mechanism is configured for advancement andretraction of a balloon catheter at least partially disposed in thehandle and catheter lumen through the handle and catheter lumen by useroperation of the balloon catheter movement mechanism.

Medical devices according to embodiments of the present invention arebeneficial in that the disposition of the guide wire movement mechanismand the balloon catheter movement mechanism on the handle of the medicaldevice, combined in some embodiments with the sliding movement of theguide wire movement mechanism and the balloon catheter movementmechanism along the handle, provides a medical device that isparticularly easy to use. For example, a physician can, if desired,operate the guide wire movement mechanism and the balloon cathetermovement mechanism with a single hand. Moreover, since the guide wiremovement mechanism is configured for guide wire rotation, locking andunlocking, in addition to guide wire advancement and retraction, ease ofuse (including single-handed use) is further increased. Moreover, theconfiguration of medical devices according to embodiments of the presentinvention enables a user to manipulate the guide catheter and guide wiresimultaneously.

FIG. 1 is a simplified perspective view of a medical device 100 for thetreatment of a sinus opening (for example, a Frontal, Maxillary orSphenoid sinus opening) according to an embodiment of the presentinvention. FIG. 1 includes a marker depicting tip up, tip left, tip downand tip right orientations of a guide tip included in medical devicesaccording to embodiments of the present invention.

FIG. 2 is a simplified side view of medical device 100. FIG. 3 is asimplified side view of medical device 100 with a guide wire and guidewire movement mechanism of the medical device in an advanced position.FIG. 4 is a simplified side view of the guide wire, balloon catheter,balloon catheter movement mechanism, guide wire movement mechanism andguide wire support of medical device 100, with a balloon working segmentof the balloon catheter shown in an inflated state for clarity. FIG. 5is a simplified perspective view of the guide wire, balloon catheter,balloon catheter movement mechanism, guide wire movement mechanism andguide wire support of FIG. 4.

Referring to FIGS. 1-5, medical device 100 for the treatment of a sinusopening includes a handle 102, a guide catheter 104, a guide wire 106, aballoon catheter 108 with a working balloon segment 110 (see FIGS. 4 and5 in particular), a guide wire movement mechanism 112, a ballooncatheter movement mechanism 114, a detachable guide tip 116 (shown witha curved (angled) tip in a “tip up” orientation), and a guide wiresupport 118 (see FIGS. 4 and 5). Alternative embodiments where the guidecatheter is integral with the guide tip will be discussed below.

Handle 102 includes a proximal end 120, a distal end 122 and has alongitudinal axis 124 (the extension of which is represented by a dashedline in FIG. 1) along the length of handle 102. Handle 102 includessuction access barb 126 and finger anchoring pegs 128 a and 128 b (seeFIG. 2). Handle 102 is sized and shaped such that medical device 100 canbe manipulated and operated by a user (such as a physician) in aconvenient and efficient single-handed manner if so desired. Handle 102can be formed of any suitable material including, for example,polycarbonate and ABS (acetonitrile butadiene styrene) and can bemanufactured using any suitable technique including, for example,injection molding of two clam shell handle halves.

Guide catheter 104 is attached to distal end 122 of handle 102 and has acatheter lumen (i.e., inner passage, not visible in the perspectives ofFIGS. 1-3) therein. Guide catheter 104 has a proximal end 130 and adistal end 132 (see FIG. 2). Guide catheter 104 can be formed of anysuitable materials including, for example, stainless steel, polymericmaterials and combinations thereof. A typical but non-limiting innerdiameter for a guide catheter is between about 0.070 and 0.150 inches.

In the embodiment of FIGS. 1-5, detachable guide tip 116 is configuredfor removable attachment to, and detachment from, distal end 132 ofguide catheter 104. However, detachable tips employed in medical devicesaccording to the present invention can be attached and detached from themedical device at any suitable location on the medical device. Forexample, the detachable guide tip can be attached anywhere along theguide catheter or at the distal end of the handle. Detachable guide tip116 can be formed of any suitable material including, for example,stainless steel, polymeric materials and combinations thereof.

Guide wire 106 is disposed at least partially in handle 102, guide wiresupport 118 and the catheter lumen of guide catheter 104. Guide wire 106can be any suitable guide wire known to one skilled in the artincluding, for example, an illuminated guide wire configured to providea user with confirmation of sinus access. Balloon catheter 108 isdisposed at least partially in handle 102 and the catheter lumen ofguide catheter 104 and can be any suitable balloon catheter known to oneskilled in the art as well as the balloon catheters described herein.

Guide wire movement mechanism 112 is operatively disposed on handle 102and configured for advancement and retraction of guide wire 106 throughhandle 102, guide wire support 118 and the catheter lumen of guidecatheter 104 by longitudinal sliding of guide wire movement mechanism112 along the length of handle. A comparison of FIGS. 2 and 3 serves toconvey how movement of guide wire movement mechanism 112 along handle102 serves to advance guide wire 106 such that guide wire 106 extendsfrom detachable guide tip 116.

Guide wire movement mechanism 112 includes an integrated guide wirelocking and rotation mechanism 134 configured for rotation of guide wire106 and for securely locking and unlocking guide wire 106 to guide wiremovement mechanism 112. Further details of such an integrated guide wirelocking and rotation mechanism are described below with respect to FIGS.11 through 14.

Once apprised of the present disclosure, one skilled in the art willrecognize that guide wire movement mechanisms employed in medicaldevices (and methods) according to the present invention are not limitedto those that are user operated via sliding along the length of thehandle. Rather, user operation of the guide wire movement mechanism canbe any suitable operation that results in operable movement of the guidewire by, for example, translation (i.e., movement that changes theposition of an object) of the guide wire movement mechanism relative thehandle or rotation of a guide wire movement mechanism component. In thisregard, the configuration of the guide wire movement mechanism wouldsupport such user operation via a suitable rack and pinion mechanism,gears, and/or electromechanical means.

Balloon catheter movement mechanism 114 is operatively disposed onhandle 102 and configured for advancement and retraction of ballooncatheter 108 through handle 102 and the guide catheter lumen bylongitudinal sliding of the balloon catheter movement mechanism alongthe handle. However, once apprised of the present disclosure, oneskilled in the art will recognize that balloon catheter movementmechanisms employed in medical devices (and methods) according to thepresent invention are not limited to those that are user operated vialongitudinal sliding along the length of the handle. Rather, useroperation of the balloon catheter movement mechanism can be any suitableoperation that results in operable movement of the balloon catheter by,for example, translation of the balloon catheter movement mechanismrelative to the handle or rotation of a balloon catheter movementmechanism component. In this regard, the configuration of the ballooncatheter mechanism would support such user operation via suitable rackand pinion mechanism, gear-based mechanisms, and/or electromechanicalmeans.

Guide wire support 118 of medical device 100 is operatively disposedwithin handle 102 and provides additional column strength to guide wire106 and prevents guide wire 106 from buckling within handle 102 duringadvancement. Guide wire support 118 includes a slit-shaped opening 136(see FIG. 5) into which guide wire 106 is fed by guide wire movementmechanism 112. Further details of guide wire supports that can beemployed in embodiments of the present invention are described below inregard to, for example, FIGS. 15A-15C, 16 and 17A-17C.

FIG. 6 is a simplified perspective view of a medical device 200 for thetreatment of a sinus opening according to an embodiment of the presentinvention. FIGS. 7A and 7B are simplified side and cross-sectionalviews, respectively, of medical device 200. FIG. 8 is a simplifieddepiction of a portion of a guide catheter and three guide tips (alsoreferred to as detachable guide tips) as can be employed in a medicaldevice according to embodiments of the present invention. FIG. 9 is asimplified cross-sectional depiction of a balloon catheter as can beemployed in medical devices according to the present invention. FIG. 10is a combined longitudinal and triple cross-sectional depiction of aportion of the balloon catheter of FIG. 9 along with a portion of aguide wire and a portion of a balloon inflation tube.

FIGS. 11 through 14 are various simplified depictions of a guide wiremovement mechanism and guide wire of medical device 200. FIGS. 15A, 15Band 15C are various simplified views of a guide wire support employed inmedical device 200, with FIG. 15B also depicting a portion of a guidewire. FIG. 16 is a simplified perspective view of the guide wire,balloon catheter, balloon catheter movement mechanism, guide wiremovement mechanism and guide wire support of medical device 200, withthe balloon working segment shown in an inflated state for clarity.FIGS. 17A, 17B and 17C are a sequence of simplified perspective views ofthe of the guide wire, balloon catheter, balloon catheter movementmechanism, guide wire movement mechanism and guide wire support of FIG.16 that depict the advancement of the guide wire including movement ofthe guide wire through a window opening of the guide wire support (FIGS.17A and 17B) and through a slit-shaped opening of the guide wire support(FIG. 17C).

Referring to FIGS. 6 through 17C, medical device 200 for the treatmentof a sinus opening includes a handle 202, a guide catheter 204, a guidewire 206 (not included in FIG. 6 but see, for example, FIGS. 7 and 8), aballoon catheter 208 with balloon working segment 209 (see FIGS. 9 and16 in particular), a guide wire movement mechanism 210, a ballooncatheter movement mechanism 212, and a detachable guide tip 214. Itshould be noted that medical device 200 differs from medical device 100in that, for example, detachable guide tip 214 of medical device 200 isstraight (i.e., has an angle of zero (0) degrees) while detachable guidetip 114 of medical device 100 has an angle. The benefits of curved andstraight detachable tips in efficiently treating various sinus openingsare discussed below.

Handle 202 includes a proximal end 216, a distal end 218 and has alongitudinal axis 220 along the length of handle 202 indicated by thedashed line in FIG. 7A. Handle 202 includes finger anchoring pegs 222 aand 222 b and is sized and shaped such that medical device 200 can bemanipulated and operated, if desired, by a user (such as a physician) ina single-handed manner.

Guide catheter 204 is attached to distal end 218 of handle 202 and has acatheter lumen (i.e., inner passage) 224 therein (see FIG. 7B). Guidecatheter 204 has a proximal end 226 and a distal end 228.

Detachable guide tip 214 of medical device 200 is configured forremovable attachment to, and detachment from, distal end 228 of guidecatheter 204. FIG. 8 depicts three exemplary, but non-limiting, guidetips 214 a, 214 b and 214 c, a portion of guide catheter 204 and guidewire 206. Attachment and detachment of guide tips in medical devicesaccording to embodiments of the present invention can be accomplishedusing any suitable means including a clip, push button, and bayonetstyle mechanism.

Guide tips 214 a, 214 b and 214 c of FIG. 8 each are configured toinclude angles (from 0 degrees to 110 degrees) that make themparticularly suitable for treatment of various sinus openings. Moreover,the detachable configuration of the guide catheter and the guide tips issuch that the guide tips can be attached to the medical device (forexample attached to the guide catheter) in a predetermined orientationwith respect to the remainder of the medical device or attached in oneorientation and then rotated into another orientation. For example, fortreatment of a Frontal sinus opening, a guide tip with an angle of 70 to90 degrees can be employed with the guide tip attached or rotated intoin a “tip right” configuration for a right-handed user operating themedical device with the user's right-hand thumb. This orientationensures the controls will be most accessible to the user's dominantdigit when the user is operating the guide wire movement mechanismand/or balloon catheter movement mechanism of the medical device.

For the treatment of the Maxillary sinuses, a preferred orientation ofthe guide tip depends on the side (e.g., Right or Left Maxillary) of thesinus opening being treated in addition to the user's dominant hand andactuating digit. For treatment of a Right Maxillary sinus opening, aguide tip with an angle of 90 to 110 degrees can be employed with theguide tip in a “tip up” orientation for a right-handed user operatingthe medical device with the user's thumb. For treatment of a LeftMaxillary sinus opening, a guide tip with an angle of 90 to 110 degreescan be employed with the guide tip in a “tip down” orientation for aright-handed user operating the medical device with the user's thumb.For treatment of a Right Sphenoid sinus opening, a guide tip with anangle of 0 to 30 degrees can be employed with the guide tip in a “tipup” orientation (if the guide tip is angled) for a right-handed useroperating the medical device with the user's thumb. For treatment of aLeft Sphenoid sinus opening, a guide tip with an angle of 0 to 30degrees can be employed with the guide tip in a “tip down” orientationfor a right-handed user operating the medical device with the user'sthumb. Table 1 summarizes a preferred guide tip angle, and the guide tiporientation for a right-handed user operating (actuating) the medicaldevice controls (i.e., the guide wire movement mechanism and the ballooncatheter movement mechanism). The orientations are as marked in FIG. 1.

TABLE 1 Tip Orientation Based on User and Sinus Type Preferred RightHanded Right Handed Guide Tip User Actuating User Actuating AngleControls with Controls with (in degrees) Thumb Forefinger Sinus Frontal70-90  Tip Right Tip Up Type Right 90-110 Tip Up Tip Left Maxillary LeftMaxillary 90-110 Tip Down Tip Right Right 0-30 Tip Up Tip Left Sphenoid(assuming an angled tip) Left Sphenoid 0-30 Tip Down Tip Right (assumingan angled tip)

Guide wire 206 is disposed at least partially in handle 202 and catheterlumen 224. Guide wire 106 can be any suitable guide wire known to oneskilled in the art including, for example, an illuminated guide wire.

Balloon catheter 208 is also disposed at least partially in handle 202and catheter lumen 224. Referring to FIGS. 9 and 10, balloon catheter208 includes an outer shaft 230, inner shaft 232 and proximal shaft 234.Balloon catheter 208 also includes a guide wire access opening 236.

Balloon catheter 208 includes a section (labeled A in FIG. 9) with aco-axial lumen design and a section (labeled B in FIG. 9) wherein theouter shaft, inner shaft and proximal shaft are joined together in amanner that provides for a transition between a co-axial configuration,a dual lumen configuration and a single lumen proximal shaft. FIG. 10(an exemplary, but non-limiting, depiction of a manner in which guidewire 206 and balloon catheter 208 can interact within handle 202 ofmedical device 200) includes three simplified cross-sectionaldepictions. Cross-sectional illustration “C” depicts a coaxialarrangement of the outer shaft and inner shaft taken along line C-C ofFIG. 10. Cross-sectional illustration “D” depicts a dual lumen (i.e.,guide wire access opening 236 and balloon catheter inflation lumen 238)configuration taken along line D-D of FIG. 10. Cross-sectionalillustration “E” (taken along line E-E of FIG. 10) depicts a singlelumen (i.e., the balloon catheter inflation lumen) configuration.

The co-axial design of segment A provides a beneficially small profileto fit into the guide shaft of medical device 200. Moreover, since thereis only a single dual lumen segment (i.e., segment B) in addition to theco-axial segment, medical devices incorporating the configuration ofFIGS. 9 and 10 require relatively low complexity manufacturing. However,once apprised of the present disclosure, one skilled in the art willrecognize that balloon catheters employed in medical devices and methodsaccording to embodiments of the present invention can have any suitableconfiguration and are not limited to the configuration of FIGS. 9 and10. For example, a balloon catheter employed in medical devices andmethods according to embodiments of the present invention can include adual lumen segment that extends to the distal end of the ballooncatheter in place of the co-axial segment depicted in FIGS. 9 and 10. Insuch a configuration, the guide wire access lumen would have an openingat the distal end of the balloon catheter through which the guide wirewould be advanced and the balloon catheter inflation lumen would have anopening at the balloon working segment for inflation of the balloonworking segment.

Moreover, construction of the balloon catheter shafts can be such thatdeleterious effects of forces (frictional or otherwise) between thecatheter shaft and the guide wire during operation of the medical deviceare minimized. For example, a lubricious liner on the catheter shaft canbe employed to minimize frictional forces between the guide wire and theballoon catheter shaft. In addition, the balloon catheter shaft can beof a braided construction to prevent collapse of the balloon catheterinner shaft onto the guide wire. Such a collapse can be of particularconcern when the balloon catheter travels through the curve of a curvedguide tip.

Balloon catheter 208 can be formed of any suitable material known to oneskilled in the art including, for example, Nylon, Pebax or PET. Theballoon catheter may be any size catheter including but not limited to3.5 mm to 7 mm in diameter (when inflated) and 12 mm to 24 mm in workinglength (for example 3.5 mm×12 mm, 5 mm×16 mm, 5 mm×24 mm, 6 mm×16 mm, 6mm×20 mm, 6 mm×24 mm, 7 mm×16 mm and 7 mm×24 mm. Moreover, ballooncatheter 208, guide catheter 204 and handle 202 can be configured suchthat balloon catheter 208 is removable from guide catheter 204 andhandle 202.

Guide wire movement mechanism 210 is operatively disposed on handle 202(see, for example, FIGS. 6, 7A and 7B) and configured for advancementand retraction of guide wire 206 through handle 202 and catheter lumen224 by user operation of guide wire movement mechanism 210. In medicaldevice 200, such user operation involves longitudinal sliding of guidewire movement mechanism 210 along handle 202.

Guide wire movement mechanism 210 includes an integrated guide wirelocking and rotation mechanism 240 configured for rotation of guide wire206 and for securely locking and unlocking the guide wire to the guidewire movement mechanism, a rail 242, and a nosepiece 244. Rail 242 isconfigured for slidably attaching guide wire movement mechanism 210 tohandle 202. Nosepiece 244 is configured to direct guide wire 206 intohandle 202 and guide wire access opening 236 of balloon catheter 208and, in the embodiment of medical device 200 into guide wire support 260of medical device 200 as described further below with respect to FIGS.11-17C.

Integrated guide wire locking and rotation mechanism 240 includes abarrel 246 and a collet axle 248 (see FIGS. 11-14 in particular). Thelocking/unlocking capability of integrated guide wire locking androtation mechanism 240 enables a user to adjust the length of the guidewire extending (distally) beyond the guide wire movement mechanism 210.

Collet axle 248 is configured to function both as a collet and as anaxle and has a longitudinal opening through which the guide wire 206passes (see FIG. 13 in particular). In the embodiment of FIGS. 11through 14, collet axle 248 is essentially cylindrical in overall shape,and when locked onto the guide wire 206 (see FIG. 12 where the depictedoverlap of the barrel and the collet axle serves to illustrate that thebarrel is compressing the collet axle onto the guide wire), rotates andtranslates with the guide wire. Collet axle 248 rotates within bearingsurfaces 250 of the guide wire movement mechanism 210 (see FIG. 13). Thecollet axle has a plurality of alternating protrusions 252 and slots 254(see FIG. 14) configured to lock (close) onto the guide wire, therebylinking rotation of the guide wire with rotation of the collet axle.Collet axle 248 exerts a strong clamping force on the guide wire whenthe collet axle is tightened via longitudinal movement of barrel 246 (asis evident from a comparison of FIG. 12 where the collet axle is lockedinto the guide wire and FIG. 13 where the collet axle is unlocked fromthe guide wire).

Barrel 246 has an essentially cylindrical cross-section and an openingtherethrough, in which collet axle 248 is disposed. The contour of thebarrel's opening is designed to receive the collet axle and has at leastone focal point configured to collapse the collet axle onto the guidewire (see FIG. 12 in particular). The exterior of barrel 246 has gripfeatures shown in the embodiment of FIGS. 11-13 as a macroscopic surfacefeature (i.e., ridges). However, such grip features could alternativelybe microscopic in nature or based on frictional material properties suchas a rubberized surface. Such grip features provide traction for theuser to rotate or translate the barrel via operation with, for example,the user's thumb or finger which rotates the wire by rotation of theaxle in which the wire is locked. The distal and proximal ends of thebarrel have a raised ring feature 256, which provides traction for theuser to translate the guide wire movement mechanism when the collet axleis in a locked position or provide a gripping feature to move the barrelrelative to the remainder of the guide wire movement mechanism to lockand unlock the axle.

Once apprised of the present disclosure, one skilled in the art willrecognize that guide wire locking and rotation mechanisms employed inmedical devices according to the present invention can take any suitableform in addition to the barrel and collet axle configurations shown in,for example, FIGS. 11 through 14. For example, the barrel could beshaped essentially as a sphere, cylinder or other suitable shape.

Balloon catheter movement mechanism 212 is operatively disposed onhandle 202 and configured for advancement and retraction of ballooncatheter 208 through handle 202 and the guide catheter lumen bylongitudinal sliding of the balloon catheter movement mechanism alongthe handle.

Referring now to FIGS. 15A through 17C in particular, medical device 200includes an optional guide wire support 260 operatively disposed withinhandle 202 of medical device 200. Guide wire support 260 providesadditional column strength to guide wire 206 and is configured toprevent guide wire 206 from buckling within handle 202.

Guide wire support 260 is configured as a thin walled tube having foursections, namely a proximal attachment section 262, a window section264, a slit section 266, and a distal attachment section 268. Moreover,guide wire support 200 has a slit-shaped opening 270 in slit section 266and a surface window opening 272 in window section 264 (see FIG. 15C).Guide wire support 260 can be formed of any suitable materialsincluding, for example, polymeric materials, stainless steel materials,titanium alloys and combinations thereof.

It is noted that inclusion of a guide wire support in medical devicesaccording to embodiments of the present invention is optional. Forexample, the guide wire support can be eliminated if other means forpreventing or minimizing guide wire buckling (e.g., a geared trackingsystem for advancing the guide wire) are provided or guide wire bucklingis not otherwise encountered during normal use of the medical device.

The sequence depicted in FIGS. 17A, 17B and 17C depict guide wiremovement mechanism 210 being advanced by a user. In FIGS. 17A and 17B,guide wire 206 exits guide wire movement mechanism 210 and enterssurface window opening 272. In FIG. 17C, the user has advanced guidewire movement mechanism 210 further such that guide wire 206 entersslit-shaped opening 270. Slit-shape opening 270 is configured such thatit opens as guide wire 206 is advanced. The slit-shape opening 270extends distally of the surface window opening 272. The slit-shapeopening 270 prevents buckling of the guide wire 206 and the surfacewindow opening 272 provides a region of lower friction for ease ofmovement of the guide wire 206 within the nasal anatomy.

Once apprised of the present disclosure, one skilled in the art willrecognize that guide wire supports employed in medical devices accordingto embodiments of the present invention can have any suitableconfiguration and are not limited to the configuration depicted in FIGS.15A through 17C. For example, a suitable guide wire support can be acylinder with a lumen and a surface window opening (with the lumen andsurface window opening configured for accepting a guide wire) and a coilor braid (e.g., a metallic or polymeric coil) wrapped around a portionof the cylinder including at least a portion of the surface windowopening or a spiral shaped surface window opening on a rotating coil ortube. In such a guide wire support, the coil or braid is configured toprevent buckling of the guide wire through the surface window openingduring advancement of the guide wire through the handle. Alternatively,the guide wire support can include a cylinder with a lumen and a surfacewindow opening (the lumen and surface window opening configured foraccepting a guide wire) and a telescoping encasement around a portion ofthe cylinder including at least a portion of the surface window opening.In this alternative, the telescoping encasement is configured to preventbuckling of the guide wire through the surface window opening duringadvancement of the guide wire through the handle.

Operation of medical device 200, including operation of guide wiremovement mechanism 210 and balloon catheter movement mechanism 212 arefurther described below with respect to FIGS. 18 through 22. FIG. 18 isa simplified side view of the medical device 200 depicting guide wiremovement mechanism 210 in an advanced position. The arrow of FIG. 18indicates the directions in which guide wire movement mechanism 210 canmove. In the advanced position of FIG. 18, guide wire movement mechanism210 has slid, for example, approximately 2.0 to 4.0 cm from the positiondepicted in FIG. 7.

FIG. 19 is a simplified side view of medical device 200 depicting guidewire movement mechanism 210 in an advanced position and with arrowsindicating the manner in which rotational movement of barrel 246 andcollet axle 248 of guide wire movement mechanism 210 serves to rotateguide wire 206.

FIG. 20 is a simplified side view of the medical device 200 depictingguide wire movement mechanism 210 in a fully advanced position that is,for example, approximately 6.0-8.0 cm from the position of FIG. 7. Sinceguide wire movement mechanism 210 is further advanced in FIG. 20 than inFIG. 19, the length of guide wire 206 extending from detachable guidetip 214 is longer in FIG. 20 than in FIG. 19.

FIG. 21 is a simplified side view of the medical device 200 depictingballoon catheter movement mechanism 212 in a fully advanced position.The arrow of FIG. 21 depicts the sliding movement direction that ballooncatheter movement mechanism 212 took to arrive at the fully advancedposition. FIG. 21 depicts balloon catheter 208 in an inflated state ascan be employed to treat a sinus opening.

FIG. 22 is a simplified side view of medical device 200 depictingballoon catheter movement mechanism 212 and guide wire movementmechanism 210 in a retracted position with the arrow indicating theirretraction direction.

In general, methods for treating a sinus opening include inserting amedical device for the treatment of a sinus opening partially into apatient's anatomy and advancing a guide wire of the medical device intothe patient's sinus via user operation of a guide wire movementmechanism of the medical device that is disposed a handle of the medicaldevice. The method also includes rotating the guide wire within thepatient's sinus via user operation of a rotating component of the guidewire movement mechanism and repeating the guide wire advancing androtating steps to position the guide wire in the sinus opening asappropriate for treatment. The method further includes advancing aballoon catheter of the medical device along the guide wire via useroperation of a balloon catheter movement mechanism of the medical devicethat is disposed on the handle of the medical device; and treating thesinus opening via inflation of the balloon catheter.

Methods according to embodiments of the present invention are beneficialin that they employ a medical device that is relatively easy to set-upand the methods themselves are easy to perform. For example, the set-upcan involve the attachment of an appropriate guide tip selected by auser from among a plurality of guide tips of various sizes and anglessupplied with the medical device (see, for example, FIG. 8). The methodsare easy to perform since, for example, the medical device can, ifdesired, be operated with one hand since both the guide wire movementmechanism and the balloon catheter movement mechanism are disposed onthe handle of the medical device. Since the methods are easy to perform,they can be performed in both a hospital operating room and a medicaloffice setting. Also, in various embodiments, the guide wire rotationand locking mechanism of the medical device employed in the methods canbe thumb operated or operated by a single finger such as a forefinger.Moreover, should a user desire to treat more than one sinus opening, theamount of preparation between sinus is reduced by the use of adetachable guide tip.

FIG. 23 is a flow diagram depicting stages in a method 300 for treatinga sinus opening (such as a Frontal, Maxillary, or Sphenoid sinusopening) according to an embodiment of the present invention. Method 300includes, at step 305, attaching a guide tip with a predetermined angleto a medical device for the treatment of a sinus opening. The attachmentof the guide tip can, if desired, be such that the guide tip has anappropriate orientation to the remainder of the medical device for thesinus opening to be treated. A preferred, but non-limiting, orientationis an orientation wherein the guide wire movement mechanism and ballooncatheter movement mechanism of the medical device face the user (forexample, a physician) during guide wire and balloon catheteradvancement.

The medical device for treatment of a sinus opening is then partiallyinserted into a patient's anatomy (see step 310 of FIG. 23). In step310, the medical device is, for example, inserted into a patient'snostril to gain access to the sinus ostia (passage). If desired, themedical device can be rotated up to 180 degrees (depending on sinustype) in either direction about the longitudinal axis of the medicaldevice following insertion.

A guide wire of the medical device is then advanced into the patient'ssinus via sliding movement of a guide wire movement mechanism of themedical device along a handle of the medical device, as noted in seestep 315 of FIG. 23.

Rotation of the guide wire within the patient's sinus via user operationof an integrated guide wire locking and rotation mechanism of the guidewire movement mechanism (for example, the barrel and collet axle ofFIGS. 11 through 14) occurs at step 320. Such rotation can be employedto, for example, obtain access to a sinus opening or during confirmationof such access using an illuminated guide wire.

At step 325, the guide wire advancing and rotating steps (i.e., steps315 and 320 of FIG. 23) are repeated as appropriate to position theguide wire in the sinus opening to be treated.

Subsequently, at step 330, a balloon catheter of the medical device isadvanced along the guide wire via sliding movement of a balloon cathetermovement mechanism of the medical device along the handle of the medicaldevice. At step 335, the sinus opening is treated via inflation of theballoon catheter. Following treatment of the sinus opening, the ballooncatheter is deflated as recited in step 340 of FIG. 23. The ballooncatheter and guide wire are then retracted into the medical device (seestep 345) and the medical device removed from the patient's anatomy (seestep 350).

Method 300 can, if desired, include an additional step of irrigating thesinus opening using the medical device. For example, followingretraction of the balloon catheter and guide wire, the treated sinusopening can be irrigated with the medical device prior to removal of themedical device from the patient's anatomy. Such irrigation can involve,as a non-limiting example, exchanging at least the balloon catheter andguide wire with a suitable irrigation cartridge such that the irrigationcartridge is operatively installed in the medical device. The operativeinstallation of the irrigation cartridge can include, for example,disposing the irrigation cartridge in the medical device such that theirrigation cartridge extends through the guide catheter and into thesinus opening with or without a guide wire. In an alternativeembodiment, the irrigation may be accomplished through an irrigationballoon catheter incorporated in the medical device.

An alternative embodiment according to the invention will now bedescribed with regard to FIG. 24 to FIG. 32. An assembled device 400 isshown with a portion of the handle 402 removed so that the device can bedescribed in detail. The medical device 400 for the treatment of a sinusopening includes a guide catheter 404, a guide wire 406, a ballooncatheter 408, a guide wire movement mechanism 410, a balloon cathetermovement mechanism 412, and a suction pathway 414. Each of the portionsof the device 400 is shown in greater detail in FIG. 25 and in FIGS.26-32. The handle 402 (shown split in two halves 402 a and 402 b in FIG.25) is ergonomically designed such that the finger anchoring pegs 416 a,416 b and 416 c can be placed between the fingers of either a righthanded or left handed user to provide for support of the device 400. Ina single-handed manner, the user's thumb can then reach the suction port418 for use of the suction pathway 414 to remove materials from theparanasal sinus or sinus canal, the guide wire movement mechanism 410for advancement and rotation of the guide wire 406 and the cathetermovement mechanism 412 for advancement of the balloon catheter along theproperly positioned guide wire 406.

In the embodiment shown with regard to FIG. 24 to FIG. 32, therepresentative guide catheter 404 has a linear (0 degree) configuration,but the guide catheter 404 can have any of the configurations shown inFIG. 26A. These guide catheters 404 a-404 f are substantially rigid andeach has a preset distal curve of 0 degrees (404 a), 30 degrees (404 b),90 degrees (404 d), 70 degrees (404 c) or 110 degrees (404 e and 404 f).Different curvatures are useable to access the ostia of differentsinuses as described above with regard to the guide tips 116 of FIG. 8,however the guide catheters 404 a-404 f described herein do not havedetachable tips. For example, a 70 degree guide is typically used toaccess the ostium of a frontal sinus, a 90 or 110 degree guide istypically used to access the ostium of a maxillary sinus, etc. Each ofthese guide catheters 404 a-404 f has a minimum path length (thelongitudinal distance through the guide catheter) of 4 cm, a maximumpath length of 25 cm, and often a path length of between about 10 and 12cm. As shown in FIGS. 26B and 26C, each guide catheter 404 has atranslucent balloon window 450 and a distal tip 452 that permitsendoscopic visualization of the placement of the guide catheter in thesinus anatomy. A rigid distal portion 454 (in this case a stainlesssteel hypotube, but which could be other similar rigid materials),provides for easy access to the sinus anatomy while the translucentballoon window 450 (in this case a nylon window but which could be othersimilar transparent materials) provides for easy visualization of theballoon. A soft guide tip 452 (which could include 20% barium sulfateand other similar radiopaque materials) provides for atraumatic,visualizable access to the target sinus.

The guide catheter 404 is connected to handle 402 over sheath 420 byclick locking the guide catheter 404 into place over sheath 420 (seeFIG. 25). Insertion of the proximal hub 428 of the guide catheter 404seats the collar 430 of the sheath 420 against the guide catheter lock424. The button 422 is spring loaded and biases the locked guidecatheter proximal hub 428 to reduce radial movement of the guidecatheter 404. As can be seen in FIG. 27B, the elastomeric valve 424further compresses against the proximal hub 428 through collar 430 ofthe sheath 420 to reduce axial movement of the guide catheter 404. Theguide catheter 404 can be positioned in any number of positions, but 8different positions may be incorporated (in addition to the tip up, tipdown, tip right and tip left orientations described in Table 1 above,the orientations can include tip up right, tip up left, tip down rightand tip down left, according to the sinus anatomy and the handedness andpreference of the user). Once properly positioned, auditory feedback (aclick) will ensure proper guide catheter locking. To remove the guidecatheter 404 from the handle 402, or to reposition the guide catheter404, the guide catheter release button 422 is depressed and the guidecatheter 404 can be rotated or slide over the sheath 420, removed, andreplaced with another guide catheter 404. In an alternative embodiment,the guide catheter (or guide tip described above) can be formed ofmalleable material that enables the user to configure the shape of theguide catheter prior to inserting the medical device into a patient'sanatomy. In this case, the guide catheter can be formed of any suitablemalleable material know to one skilled in the art. An exemplary butnon-limiting malleable material is heat treated (e.g. annealed)stainless steel. Further, the guide catheter may be steerable such thatonce in the patient's anatomy, it can alter its shape to conform to thesinus pathway.

Referring again to FIG. 25, in addition to the handle 402, guidecatheter 404 and guide catheter lock 424, the suction pathway 414 allowsfor suction of blood or other matter from the sinus cavity. As shown ingreater detail in FIG. 28, suction luer 432 can be attached to anappropriate source of suction and the sinus cavity can be suctionedthrough the guide catheter 404 and the suction pathway 414, whilecovering the suction port 418 with the thumb to increase the strength ofsuction through the pathway.

Further shown in FIG. 25 are the balloon catheter 408 and ballooncatheter movement mechanism 412 and the guide wire 406 and guide wiremovement mechanism 410. The guide wire movement mechanism 410 is shownin detail in FIG. 29 and allows for advancing, retracting and rotatingthe guide wire 406. The mechanism 410 integrates a guide wire lockingand rotation mechanism 434 configured for rotation of the guide wire 406and for securely locking and unlocking the guide wire 406 to the guidewire movement mechanism 410 as further described with regard to guidewire locking and rotation mechanism 240 above. Included in FIG. 29 isclicker 438, a flexible material, in this case a flexible strip, thatinteracts with the fins of collet 436 to provide audible and tactilefeedback of rotation of the locking and rotation mechanism 434 and theresultant rotation of the guide wire 406. A representative guide wire406 incorporated in the device 400 of the invention is the Relieva LumaSentry™ Sinus Illumination System manufactured by Acclarent, Inc., MenloPark, Calif., a guide wire system that can be connected to a lightsource for illumination and subsequent transcutaneous visualization ofthe sinus cavity.

The balloon catheter 408, balloon catheter movement mechanism 412, andthe balloon catheter shaft 460 are shown in detail in FIGS. 30A, 30B,and 30C. FIG. 30A shows the balloon catheter shaft 460 from above withthe dilation balloon 462 on the distal portion 464 of the shaft 460 andan inflation luer 466 at the proximal portion 468 of the shaft. As shownin FIG. 30B, between the balloon catheter movement mechanism and themid-catheter joint 470 shown in FIG. 30C, the catheter shaft 460comprises a shaft rail 472 (in this case constructed of a 304 stainlesssteel hypotube with an inner polymeric sleeve, but which may be anysimilar materials). The shaft rail 472 has a slit 474 (an opening in thehypotube and a cut in the sleeve) that allows for passage of the guidewire 406 from the balloon guide wire movement mechanism 412 and into theguide wire lumen 476 of the balloon catheter. The rail 472 and slit 474allow for easy movement of the guide wire 406 while preventing itsbuckling. As described above with regard to FIG. 10, the mid-catheterjoint 470 of the balloon catheter shaft 460 transitions from a ballooncatheter shaft 460 with a single inflation lumen 478 at its proximalportion 480 to a middle section 482 dual lumen portion that consists ofa guide wire lumen 476 and an inflation lumen 478 and finally to adistal portion 484 of the balloon catheter shaft 460 with a coaxiallumen 486 that has an inner guide wire lumen 488 and an outer inflationlumen 490. Both the guide wire lumen and the balloon catheter lumenproximal to the mid-catheter joint are constructed of a stainless steelhypotube. In the proximal section 480 the inflation lumen 478 is roundin cross-section, in the middle section 482 the inflation lumen 492 isoval in cross-section (it is below the guide wire lumen), and theinflation lumen transitions to a coaxial configuration.

Prior to operation of the device, the guide wire movement mechanism 410and the balloon catheter movement mechanism 412 are locked in place asshown FIGS. 31A and 31B. The guide wire lock 500 connects the guide wiremovement mechanism 410 and the balloon catheter mechanism 412 and holdsthe wire 206 stationary, preventing inadvertent movement of the guidewire 206, which prevents the wire from slipping when the barrel 246 isunlocked (see FIG. 13). Once the guide wire lock 500 is removed, theguide wire movement mechanism 410 can be moved independently down theshaft rail 472. The detent 502 prevents inadvertent movement of theguide wire 406 unless the guide wire movement mechanism 410 is moved orunless the guide wire movement mechanism is bypassed. As shown in FIG.32, where desired at the preference of the user, the guide wire 406 canbe manipulated by the user without the use of the guide wire movementmechanism 410 by removing the guide wire 406 from the balloon cathetermovement mechanism 412 and the guide wire movement mechanism 410 andthreading the guide wire 406 through the opening 510 in the ballooncatheter mechanism 412 and over the guide wire movement mechanism 410,effectively bypassing it.

The spring-loaded locking tab 504 prevents the balloon cathetermechanism 412 from moving proximally when it is in the up position, butallows for movement distally (see FIG. 31D) when activated by the thumbor finger. When the locking tab 504 is in the down position, the ballooncatheter 408 and guide wire 406 can be removed such that an irrigationcatheter can be inserted into the handle 402 and through the guidecatheter 404.

Once apprised of the present disclosure, one skilled in the art willrecognize that methods according to embodiments of the present inventionincluding method 300 can be readily modified to incorporate any of thetechniques, benefits and characteristics of medical devices according toembodiments of the present invention and described herein. Moreover, oneskilled in the art will also recognize that methods according toembodiments of the present invention, including method 300, can bemodified to incorporate suitable sinus opening treatment techniques andsteps known to one skilled in the art including suitable techniques andsteps described in U.S. Pat. Nos. 7,462,175, 7,500,971 and 7,645,272,and U.S. Patent Application Publications 2008/0097154, and 2008/0281156,each of which is hereby incorporated in full by reference. Further, thedevice and methods according to the present invention may be used, inaddition to the treatment of the nasal anatomy, for the treatment or anopening or passageway into the paranasal sinus ostium, a paranasal sinusor a Eustachian tube opening.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that devicesand methods within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A medical device for the treatment of a sinusopening, the medical device comprising: a handle with: a proximal end; adistal end; and a longitudinal axis along the length of the handle; aguide catheter attached to the distal end of the handle, the guidecatheter having a catheter lumen; a guide wire movement mechanismoperatively disposed on the handle; and a balloon catheter movementmechanism operatively disposed on the handle; wherein the handle and thecatheter lumen are configured for operatively accepting a guide wire anda balloon catheter; and wherein the guide wire movement mechanism isconfigured for advancement and retraction of a guide wire disposed atleast partially in the handle and the catheter lumen through the handleand the catheter lumen by user operation of the guide wire movementmechanism; and wherein the guide wire movement mechanism includes anintegrated guide wire locking and rotation mechanism configured forrotation of the guide wire and for securely locking and unlocking theguide wire to the guide wire movement mechanism; and wherein the ballooncatheter movement mechanism is configured for advancement and retractionof a balloon catheter disposed at least partially in the handle and inthe catheter lumen through the handle and catheter lumen by useroperation of the balloon catheter movement mechanism.
 2. The medicaldevice of claim 1 further including: a guide wire disposed at leastpartially in the handle and catheter lumen; and a balloon catheterdisposed at least partially in the handle and the catheter lumen.
 3. Themedical device of claim 1 wherein the balloon catheter movementmechanism is configured for advancement and retraction of the ballooncatheter through the handle and catheter lumen by user operation of theballoon catheter movement mechanism involving translation of the ballooncatheter movement mechanism relative to the handle.
 4. The medicaldevice of claim 3 wherein the balloon catheter movement mechanism isconfigured for advancement and retraction of the balloon catheterthrough the handle and catheter lumen by user operation of the ballooncatheter movement mechanism involving longitudinal sliding of theballoon catheter movement mechanism along handle.
 5. The medical deviceof claim 1 wherein the balloon catheter movement mechanism is configuredfor advancement and retraction of the balloon catheter through thehandle and catheter lumen by user operation of the balloon cathetermovement mechanism involving rotation of at least a portion of theballoon catheter movement mechanism.
 6. The medical device of claim 1wherein the guide wire movement mechanism is configured for advancementand retraction of the guide wire through the handle and the catheterlumen by user operation of the guide wire movement mechanism involvingtranslation of the guide wire movement mechanism relative to the handle.7. The medical device of claim 1 wherein the guide wire movementmechanism is configured for advancement and retraction of the guide wirethrough the handle and the catheter lumen by user operation of the guidewire movement mechanism involving longitudinal sliding of the guide wiremovement mechanism along the handle.
 8. The medical device of claim 1wherein the guide catheter is configured for attachment, detachment andreattachment to the handle.
 9. The medical device of claim 1 furtherincluding a guide tip, and wherein the guide tip is configured forattachment, detachment and reattachment of the guide tip to the guidecatheter.
 10. The medical device of claim 9 wherein the guide catheterand the guide tip are configured for attachment, detachment andreattachment of the guide catheter to the handle.
 11. The medical deviceof claim 1 further comprising an irrigation system for irrigating theparanasal sinus or sinus canal.
 12. The medical device of claim 1further comprising a suction pathway for removal of materials from theparanasal sinus or sinus canal.
 13. The medical device of claim 1further including a guide wire support disposed within the handle,wherein the guide wire is at least partially disposed within the guidewire support; and wherein the guide wire support is configured toprevent buckling of the guide wire within the handle during advancementof the guide wire through the handle.
 14. The medical device of claim 13wherein the guide wire support is generally cylindrical in shape andincludes a slit-shaped opening; and wherein the slit-shaped opening isconfigured such that, during advancement of the guide wire, the guidewire enters the guide wire support through the slit-shaped opening. 15.The medical device of claim 1 wherein the guide wire locking androtation mechanism includes: a barrel with an axial openingtherethrough; and a collet axle at least partially disposed within theaxial opening of the barrel.
 16. The medical device of claim 1 whereinthe guide wire movement mechanism further includes at least one railconfigured for sliding movement of the guide wire mechanism along alength of the handle during advancement and retraction of the guidewire.
 17. The medical device of claim 1 wherein the balloon cathetermovement mechanism further includes at least one rail configured forsliding movement of the balloon catheter mechanism along a length of thehandle during advancement and retraction of the balloon catheter. 18.The medical device of claim 1 wherein the guide wire movement mechanismand the balloon catheter movement mechanism are disposed on the handlein a configuration for single-handed operation of both the guide wiremovement mechanism and the balloon catheter movement mechanism by auser.
 19. The medical device of claim 18 wherein the guide wire movementmechanism and the balloon catheter movement mechanism are disposed onthe handle in an in-line configuration along the length of the handle.20. The medical device of claim 18 wherein the guide wire movementmechanism and the balloon catheter movement mechanism are disposed onthe handle in a side-by-side configuration.
 21. The medical device ofclaim 1 wherein the sinus opening is at least one of a Frontal sinusopening, Maxillary sinus opening, and Sphenoid sinus opening.
 22. Themedical device of claim 1 wherein the guide wire locking and rotationmechanism is configured for thumb-operated rotation of the guide wire.23. The medical device of claim 1 wherein the guide wire locking androtation mechanism is configured for single finger operated rotation ofthe guide wire.
 24. A method for treating a sinus opening, the methodcomprising: inserting a medical device for the treatment of a sinusopening partially into a patient's anatomy; positioning the medicaldevice in the sinus opening; advancing a guide wire of the medicaldevice into the patient's sinus via user operation of a guide wiremovement mechanism of the medical device disposed on a handle of themedical device; rotating the guide wire within the patient's anatomy viauser operation of an integrated guide wire locking and rotationmechanism of the guide wire movement mechanism; repeating the guide wireadvancing and rotating steps to position the guide wire in the sinusopening as appropriate for treatment; advancing a balloon catheter ofthe medical device along the guide wire via user operation of a ballooncatheter movement mechanism of the medical device disposed on the handleof the medical device; and treating the sinus opening via inflation ofthe balloon catheter.
 25. The method of claim 24 wherein the advancingof the guide wire includes user operation of the guide wire movementmechanism involving translation of the guide wire movement mechanismrelative to the handle.
 26. The method of claim 24 wherein the advancingof the guide wire includes user operation of the guide wire movementmechanism involving longitudinal sliding of the guide wire movementmechanism along the handle.
 27. The method of claim 24 wherein theadvancing of the balloon catheter includes user operation of the ballooncatheter movement mechanism involving translation of the ballooncatheter movement mechanism relative to the handle.
 28. The method ofclaim 24 wherein the advancing of the balloon catheter includes useroperation of the balloon catheter movement mechanism involvinglongitudinal sliding of the balloon catheter movement mechanism alonghandle.
 29. The method of claim 24 wherein the advancing of the ballooncatheter includes user operation of the balloon catheter movementmechanism involving rotation of at least a portion of the ballooncatheter movement mechanism.
 30. The method of claim 24 furtherincluding: deflating the balloon catheter; retracting the ballooncatheter and the guide wire; and removing the medical device from thepatient's anatomy.
 31. The method of claim 24 further including:attaching, prior to the inserting step, a detachable guide tip to themedical device in an orientation appropriate for the sinus opening to betreated.
 32. The method of claim 24 further including; attaching, priorto the inserting step, a detachable guide catheter to the medical devicein an orientation appropriate for the sinus opening to be treated. 33.The method of claim 24 wherein the guide wire advancing step includesadvancing the guide wire through a guide wire support disposed in thehandle of the medical device and configured to prevent buckling of theguide wire in the handle.
 34. The method of claim 33 wherein the guidewire support is essentially cylindrical in shape and includes aslit-shaped opening through which the guide wire is directed by theguide wire movement mechanism.
 35. The method of claim 24 wherein thepatient's anatomy is a nostril.
 36. The method of claim 24 wherein thesinus opening is one of a Frontal sinus opening, Maxillary sinusopening, and Sphenoid sinus opening.
 37. The method claim 24 wherein theguide wire movement mechanism and the balloon catheter movementmechanism are disposed on the handle in a configuration forsingle-handed user operation of both the guide wire movement mechanismand the balloon catheter movement mechanism by a user.
 38. The method ofclaim 37 wherein the guide wire movement mechanism and the ballooncatheter movement mechanism are disposed on the handle in an in-lineconfiguration along the length of the handle.
 39. The method of claim 28wherein the guide wire locking and rotation mechanism is configured forthumb-operated rotation of the guide wire.
 40. The method of claim 24further including irrigating the sinus opening using the medical device.41. The method of claim 40 wherein the irrigating is accomplished usingan irrigation cartridge installed in the medical device.
 42. The methodof claim 40 wherein the irrigating is accomplished using an irrigationballoon catheter incorporated into the medical device.
 43. The method ofclaim 24 further including suctioning the sinus opening using themedical device.